Gastro Concepts Air Assist— 510(k) K242668

Name: FDA 510(k) clearance K242668
Creator: U.S. Food and Drug Administration
Published: 2024-12-13

Substantially Equivalent

Gastro Concepts, LLC

FDA 510(k) clearance K242668 for Gastro Concepts Air Assist, Substantially Equivalent on 2024-12-13. Applicant: Gastro Concepts, LLC. Device class: 2.

Clearance details

Applicant: Gastro Concepts, LLC
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-05
Decision date: 2024-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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